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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K872218
Device Name COOL SHADES
Applicant
Mattel, Inc.
5150 Rosecrans Ave.
Hawthorne,  CA  90250
Applicant Contact STEPHEN L HARTLEY
Correspondent
Mattel, Inc.
5150 Rosecrans Ave.
Hawthorne,  CA  90250
Correspondent Contact STEPHEN L HARTLEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/09/1987
Decision Date 06/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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